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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00780-3
Product Name/Description Access Immunoassay Systems Access Folate Calibrators, Part numbers: A14207, A98033. An in vitro diagnostic medical device (IVD)

Part Number: A14207
Lot Numbers: 112788 (Expiry Date 30 JUN 2012); 115741 (31 AUG 2012); 118917 (31 OCT 2012)

Part Number: A98033
Lot Numbers: 122651 (31 JUL 2012); 123635 (30 SEP 2012); 219962 (31 OCT 2012)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/08/2012
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue Beckman Coulter has confirmed that the stability, while frozen, for the Access Folate calibrators may produce falsely elevated results which could mask a folate deficiency. Product Number A14207 may experience this issue at 12 months, and Product Number A98033 at 6 months.
Recall Action Recall
Recall Action Instructions Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications.
Contact Information 1800 060 881 - Beckman Coulter Customer Support Centre